Pseudoephedrine HCl 30 mg/1
Pseudoephedrine HCl · TABLET, FILM COATED · Major Pharmaceuticals
Pseudoephedrine HCl is a tablet, film coated containing pseudoephedrine hcl at 30 mg/1, taken oral. Manufactured by Major Pharmaceuticals.
Key Facts
- Brand Name
- Pseudoephedrine HCl
- Generic Name
- Pseudoephedrine HCl
- NDC Code (Product)
0904-6990- Manufacturer
- Major Pharmaceuticals
- Strength
- 30 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- M012
- Marketing Start
- 08/12/2019
Recall History
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Sun Pharmaceutical Industries, Inc.
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications
Dr. Reddy's Laboratories, Inc.
Failed dissolution specifications
Jaymac Pharmaceuticals L.L.C.
Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
Dr. Reddy's Laboratories, Inc.
Failed dissolution specifications
Dr. Reddy's Laboratories, Inc.
Failed dissolution specifications
Dr. Reddy's Laboratories, Inc.
Failed dissolution specifications
Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses temporarily relieves these symptoms associated with the common cold or flu: headache sinus pressure nasal congestion minor body aches and pains fever
Dosage & Administration
Directions ● do not take more than directed ● the smallest effective dose should be used ● adults and children 12 years of age and over: ● take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used. ● do not use more than 6 capsules in any 24-hour period unless directed by a doctor ● children under 12 years of age: do not use Other information each capsule contains: potassium 20 mg store at 20° to 25°C (68° to 77°F). Avoid excessive heat above 40°C (104°F). read all warnings and directions before use. Keep carton.
Warnings
Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Frequently Asked Questions
What is Pseudoephedrine HCl used for?
Pseudoephedrine HCl contains Pseudoephedrine HCl. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Pseudoephedrine HCl a controlled substance?
Pseudoephedrine HCl is not classified as a controlled substance by the DEA.
What is the generic name for Pseudoephedrine HCl?
The generic name for Pseudoephedrine HCl is Pseudoephedrine HCl. There are 12 other brand versions of Pseudoephedrine HCl.
What is the NDC code for Pseudoephedrine HCl 30 mg/1?
The NDC (National Drug Code) for Pseudoephedrine HCl 30 mg/1 is 0904-6990, listed by Major Pharmaceuticals.
Other Pseudoephedrine Brands
See all →- pseudoephedrine hydrochloride30 mg/145802-432
- SUDOGEST NASAL DECONGESTANT30 mg/150090-4345
- Sinus and Nasal Decongestant30 mg/151316-121
- Leader 12 Hour Sinus Nasal Decongestant120 mg/170000-0735
- pseudoephedrine hydrochloride30 mg/185766-049
- Nasal Decongestant Maximum Strength30 mg/121130-112
- Sinus and Congestion Non-Drowsy30 mg/149035-780
- Nasal Decongestant30 mg/163187-344
- Nasal Decongestant30 mg/10536-3607
- Sinus Decongestion30 mg/130142-641
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)